Sofwave Medical Ltd announces the US Food and Drug Administration (FDA) clearance of additional indications, for lifting the eyebrow and lifting lax submental tissue (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental neck regions, for subjects aged 22 or older.
In addition, the Sofwave system featuring the company’s proprietary SUPERB technology is also cleared by the US FDA for a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles.
To support the expansion of indications, Sofwave Medical conducted a multi-site, clinical study that evaluated the safety and effectiveness of the device for the non-invasive dermatological aesthetic treatment to lift the eyebrow and lift lax submental and neck tissue.
A total of 80 subjects received treatments at five investigational sites in the United States. Overall, 467 facial areas were treated during the study course.
“This major clearance complements our earlier received approval to market SUPERB for reduction of facial lines and wrinkle. Further, this study demonstrates the breadth of our proprietary Synchronous Ultrasound Parallel Beam Technology SUPERB to address additional high-volume indications.”— Sofwave’s Chief Executive Officer Louis Scafuri
“The FDA clearance represents another major achievement for the Sofwave platform and showcases Sofwave Medical’s ongoing focus on innovation and clinical advancements in energy-based technology.
“The SUPERB (Synchronous Ultrasound Parallel Beam) is a unique, industry-leading technology offering practitioners a non-invasive treatment for high demand lifting treatments of face and neck. We will continue to develop innovative products that advance the medical aesthetics industry and meet the needs of our customers and the needs of their patients.”— Dr. Shimon Eckhouse, Chairman of the Board of Directors and Co-founder of Sofwave Medical
[Source(s): Sofwave, PR Newswire]